Section h10: the real intelligence tracking camera (spain), rob10025, serial number (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Observed red led blinking and camera beeping when powered on.Followed procedure to reset shock sensor and charge camera for 2 hours.Shock sensor reset was successful, battery charged and no longer depleted.Completed camera accuracy verification using cori system, test passed.The most likely cause of this event is the depletion/interruption of the shock sensor battery (the shock sensor is triggered during transport, which causes the system to use the battery up).A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the documented risk file will undergo further investigation by the site quality team.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.Internal complaint reference number: (b)(4).
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